Bayer and its US development and marketing partner, Johnson & Johnson, announced that they will not provide a complete response to the FDA this year regarding their request to market Xarelto (rivaroxaban) for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee surgery. Bayer had previously stated that the response would be submitted in the current quarter at the earliest.

Bayer and Johnson & Johnson explained on Sunday that following discussions with the FDA, the companies are working "to provide additional information from the RECORD study sites, and data from ongoing studies, to adequately address issues raised in the [FDA] complete response letter received in May 2009."

Bayer stated that it expects to provide a further update on the filing strategy for Xarelto on February 28, 2010.

Reference Articles

Phase III-extension study of Bayer’s rivaroxaban shows significant benefit in the prevention of secondary symptomatic VTE - (Bayer)

Bayer to communicate rivaroxaban filing strategy update in Feb - (CNN Money)

Bayer, J&J take more time in bid to convince FDA - (Forexyard)